← FDA Medical Device Classifications

Instrument, Coagulation, Automated

GKP · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.5400

Classification

FDA Product Code

GKP

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 864.5400

Review panel

HE

Medical specialty

Hematology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

49

Registered establishments

17

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown